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Tests treatment safety and results for Rheumatoid Arthritis (RA)
Official title Safety, Tolerability, and PK/PD of CIGB-814 in Chinese Health Participants
ClinicalTrials.gov ID: NCT07182656
What this study is testing
What is CIGB-814 (single-dose group)?
CIGB-814 (single-dose group) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for rheumatoid arthritis (ra).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of CIGB-814 for injection after single and multiple administrations in healthy participants. Secondary objectives include the assessment of preliminary pharmacodynamics (PD) and immunogenicity.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Participants must meet all of the following criteria to be eligible for the study:
- Healthy male or female participants aged 18 to 45 years, inclusive.
- Male participants weighing at least 50.0 kg, and female participants weighing at least 45.0 kg, with a body mass index (BMI) between 19.0 and 26.0...
- Able to communicate effectively with the investigators, understand and comply with all study requirements, and willing to adhere strictly to the...
- From the date of signing the informed consent until 6 months after study completion, participants must not have plans for conception. Female...
You likely can't join if
- Participants meeting any of the following criteria will be excluded from the study: 1.History or presence of any clinically significant disease...
- Respiratory (e.g., past or active tuberculosis), cardiovascular, gastrointestinal, urinary, musculoskeletal, endocrine (e.g., adrenal insufficiency)...
- Fever or infectious disease within 3 days prior to screening;
- History of gastrointestinal, liver, or kidney diseases, including prior partial resection of these organs;
- Severe infection, trauma, or surgery within 12 weeks prior to screening, or planned surgery during the study deemed unsuitable by the investigator;
- Clinically significant acute illness (e.g., gastrointestinal disorders, infections) within 4 weeks prior to screening;
See the full eligibility criteria
- Participants must meet all of the following criteria to be eligible for the study:
- Healthy male or female participants aged 18 to 45 years, inclusive.
- Male participants weighing at least 50.0 kg, and female participants weighing at least 45.0 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m², inclusive (BMI = weight [kg] / height² [m²]).
- Able to communicate effectively with the investigators, understand and comply with all study requirements, and willing to adhere strictly to the study procedures and follow-up schedule. Participants must provide written...
- From the date of signing the informed consent until 6 months after study completion, participants must not have plans for conception. Female participants must not have plans to donate oocytes and agree to use reliable...
- Participants meeting any of the following criteria will be excluded from the study: 1.History or presence of any clinically significant disease, including but not limited to:
- Respiratory (e.g., past or active tuberculosis), cardiovascular, gastrointestinal, urinary, musculoskeletal, endocrine (e.g., adrenal insufficiency), neurological or psychiatric (e.g., epilepsy), hematologic...
- Fever or infectious disease within 3 days prior to screening;
- History of gastrointestinal, liver, or kidney diseases, including prior partial resection of these organs;
- Severe infection, trauma, or surgery within 12 weeks prior to screening, or planned surgery during the study deemed unsuitable by the investigator;
- Clinically significant acute illness (e.g., gastrointestinal disorders, infections) within 4 weeks prior to screening;
- Chronic pain (persistent or recurrent for \>3 months) or currently experiencing acute pain (\ 8 cups/day, 1 cup = 250 mL) within 3 months prior to screening. 6.Inability to refrain from caffeine-containing foods or...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.